BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIGH VISCOSITY SPINAL CEMENT

    MDR report key: 6751583 · Received July 28, 2017

    Report

    Report Number
    1526439-2017-10620
    Event Type
    Injury
    Date Received
    July 28, 2017
    Report Date
    July 10, 2017
    Manufacturer
    DEPUY-SYNTHES SPINE
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THIS COMPLAINT WAS GENERATED FROM LITERATURE REVIEW CONDUCTED IN POST MARKET SURVEILLANCE (PMS) FOR HEALTH AUTHORITY REPORTING PURPOSES. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE PMS IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. LITERATURE COMPLAINT.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE. LI, B., WANG, Q., YU, Y., DU, W., & SHAO, G. (2011). CONFIDENCE HIGH VISCOSITY BONE CEMENT SYSTEM AND POSTURAL REDUCTION IN TREATING ACUTE SEVERE OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES. ZHONGGUO XIU FU CHONG JIAN WAI KE ZA ZHI= ZHONGGUO XIUFU CHONGJIAN WAIKE ZAZHI= CHINESE JOURNAL OF REPARATIVE AND RECONSTRUCTIVE SURGERY, 25(3), 307-310. (RECEIVED: SEP 21, 2010 REVISED: NOV 18, 2010). N=3: CEMENT LEAKAGE DURING OPERATION. (2) INTO INTERVERTEBRAL SPACE (1) INTO ADJACENT PARAVERTEBRAL SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531829 HIGH VISCOSITY SPINAL CEMENT CEMENT, BONE, VERTEBROPLASTY NDN DEPUY-SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other